Lilly abandons tabalumab for rheumatoid arthritis

Decision based on lack of efficacy in late-stage trials

Lilly has halted its efforts to develop tabalumab as a new treatment for rheumatoid arthritis after the drug disappointed in late-stage trials.

The US-based pharma company said it expects to take a hit of $50m in the first quarter of 2013 as a result of the terminated programme.

Lilly's announcement comes nearly two months after it suspended a phase III trial investigating tabalumab in the treatment of patients with moderate-to-severe RA who had not responded to prior therapy with the methotrexat after an interim analysis suggested it would miss efficacy targets.

The disappointing findings in this study, known as FLEX-M, led Lilly to conduct an analysis of the related FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumour necrosis factor (TNF) inhibitors.

Following both analyses, the whole programme has now been shut down, with Lilly's VP of autoimmune product development Dr Eiry Roberts stating he was “disappointed” by the results.

However, he did add that he still has hopes that tabalumab's method of inhibiting the B cell activating factor (BAFF) could be useful in other indications.

"Autoimmune disorders are highly individualised,” said Dr Roberts. “We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing phase III tabalumab lupus programme."

This programme is investigating tabalumab's use in the treatment of systemic lupus erythematosus, an autoimmune condition that can cause inflammation in person's skin, joints, kidneys, brain and other organs.

If it does prove its efficacy in this indication, it would provide competition to GSK's Benlysta, which in 2011 became the first drug approved for lupus in more than 50 years.